MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-12-20 for CERTEX SPINAL FIXATION SYSTEM X067-0466 manufactured by X-spine Systems, Inc..
[179294927]
The complainant reported that following use of a tap, it was identified that the tap was broken. The broken portion of the tap was recovered and there was an additional tap available to complete the surgery. There were no reported patient complications. The complaint device was not returned for complaint assessment, it was discarded at the hospital. Visual and functional assessments could not be performed. A dhr review was performed for lot# 4640 and there were no manufacturing anomalies identified. The device met all required specifications prior to being initially released on 11/11/2013. It may be possible that the tap could break if the tap or associated tap guide was inadvertently shifted while in use. If the tap or tap guide was shifted laterally while in use, it could concentrate applied force to the portion of the tap shaft with minimal material, resulting in an instrument malfunction.
Patient Sequence No: 1, Text Type: N, H10
[179294928]
The complainant reported that following use of a tap, it was identified that the tap was broken. The broken portion of the tap was recovered and there was an additional tap available to complete the surgery. There were no reported patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2019-00051 |
| MDR Report Key | 9501113 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-12-20 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-11-22 |
| Date Mfgr Received | 2019-11-22 |
| Device Manufacturer Date | 2013-11-11 |
| Date Added to Maude | 2019-12-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CASEY MING |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal | 59714 |
| Manufacturer Phone | 4063880480 |
| Manufacturer G1 | X-SPINE SYSTEMS, INC. |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 59714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERTEX SPINAL FIXATION SYSTEM |
| Generic Name | SPINAL IMPLANTS |
| Product Code | HWX |
| Date Received | 2019-12-20 |
| Model Number | X067-0466 |
| Lot Number | 4640 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | X-SPINE SYSTEMS, INC. |
| Manufacturer Address | 664 CRUISER LANE BELGRADE MT 59714 US 59714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-20 |